Prospective, Randomized, Multi-center Clinical Study of Plasma Disc Decompression

Completed · Phase 4

Conditions studied: Radicular Pain

In brief

The goal of this post-marketing surveillance study is to compare two procedures which are used to treat patients who require a disc decompression procedure. These procedures are: 1) plasma disc decompression procedure using Coblation technology and 2) fluoroscopy guided transforaminal epidural steroid injection (TFESI). The study will evaluate treatment efficacy and rate of improvement in symptoms through the first six months following the procedure. The principal objectives of this study are to determine whether subjects receiving the plasma disc decompression procedure demonstrate: 1. Improved clinical outcomes over subjects receiving TFESI 2. More rapid reversal of symptoms than subjects receiving TFESI

Key facts

Study ID: NCT00189605
Run by: ArthroCare Corporation
People needed: 90
Starts: 2004-09-01
Expected to finish: 2009-04-01
Last updated by the study team: 2015-08-26

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patient has one symptomatic contained, focal herniated lumbar disc.
Patient's age should be at least 18 years old and no more than 75 years old.
Selective nerve root injection or epidural steroid injection for symptomatic herniated disc, received between 3 weeks and six months ago.
A VAS score for radicular pain of 50 or greater on a scale of 0 to 100.
Radicular pain concordant with image findings (MRI or CT).
Disc height greater than 50%.
Patient signs informed consent.

You may not qualify if…

Patient is pregnant, or pregnancy is suspected or planned within the study timeframe.
Patient is receiving Worker's compensation or is in litigation related to back/leg pain.
Patient has a cardiac pacemaker, automatic defibrillator, or any peripheral stimulator leads in the lumbar area.
Allergy to contrast media or drugs to be used in the intended procedure.
Medical co-morbidities that preclude surgical intervention.
Patient is receiving anti-psychotic therapy.
Patient is a prisoner.
Patient is incapable of understanding or responding to the study questionnaires.
History of previous spinal surgery at, or directly adjacent to, the level to be treated.
Patient is morbidly obese (BMI ≥ 40).
Patient is simultaneously participating in another device or drug study related to limb/axial pain.
Patient has a spinal fracture, tumor or infection.
Radicular pain originating from more than one disc level.
Axial (back) pain greater than radicular (leg) pain.
Clinical evidence of cauda equina syndrome.
Progressive neurologic deficit.
Radiological evidence of spondylolisthesis at the level to be treated.
Radiological evidence of moderate/severe stenosis at the level to be treated.
Evidence of extruded or sequestered disc herniation on magnetic resonance imaging.

Where it is running

The Orthopedic Clinic Association — Scottsdale, Arizona, United States
Innovative Spine Care — Little Rock, Arkansas, United States
SpectrumCare Rehabilitation Medical Center Inc. — Napa, California, United States
North Valley Rehabilitation Hospital — Thornton, Colorado, United States
Beth Israel Deaconess Medical Center, Arnold Pain Management Center, — Boston, Massachusetts, United States
The University of Michigan, The Spine Program — Ann Arbor, Michigan, United States
Medical Advanced Pain Specialists (MAPS) — Edina, Minnesota, United States
TRIA Orthropaedic Center — Minneapolis, Minnesota, United States
OrthoCarolina — Charlotte, North Carolina, United States
University of Pittsburgh Medical Center (UPMC) Presbyterian — Pittsburgh, Pennsylvania, United States
Western Pennsylvania Hospital — Pittsburgh, Pennsylvania, United States
Consultants in Pain Research — San Antonio, Texas, United States
University of Vermont College of Medicine, Center for Pain Mgmt — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

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